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Pain Claims: Navigating pain-relief supplement claims

The brands participating in Radicle ACES. Courtesy of Radicle Science.

Radicle Science (San Diego, CA), a healthtech B-corp that validates natural products, has announced the launch of the 

Radicle ACES (Advancing CBD Education and Science) study

. The study will utilize Radicle Science’s proprietary data analytics platform and a virtual, direct-to-consumer (D2C) model to deliver objective health outcome data across diverse populations and conditions. This will be the most comprehensive randomized controlled trial of its kind, collecting data on thirteen U.S. CBD brands: Altwell, Charlotte’s Web, Columbia Care, Healer, Lord Jones, Maven Hemp, MD Farma, Peels (a citrus-derived brand), Prospect Farms, Puraura Naturals from Enhanced Botanicals, Rae Wellness, Trokie, and Verséa Wellness.

The four-week Institutional Review Board-approved study will evaluate the effectiveness of CBD on well-being, quality of life, pain, sleep disturbance, and anxiety across nearly 3000 participants throughout the U.S. Radicle Science uses a 100% virtual, direct-to-consumer approach. Participants won’t have to travel to in-person visit, and surveys are short, taking a total of 40-45 minutes.

“A rigorous scientific study of this magnitude has never before been conducted in the CBD market,” said Pelin Thorogood, co-founder and executive chair of Radicle Science, in a press release. “Radicle ACES is driven by our deep commitment to contribute to the body of evidence to support growing demand from consumers and healthcare providers. Given the scale, the diversity of the participant population and the wide range of high-quality commercial brands included, Radicle ACES promises to deliver rich, objective health outcome data for a variety of common health conditions, with the potential to offer unprecedented guidance on CBD effectiveness based on demographic or behavioral differences.”

The study will capture health outcome data from a highly heterogenous population that includes a variety of ethnicities, age groups, geographies, behavioral habits, and pre-existing health conditions. Participants will be randomized to receive one of the 13 brands at the start of the study or be assigned to a control arm. In addition, Radicle will send a random sample of each CBD product used in the study to the same accredited third-party testing lab to be analyzed for active ingredients such as cannabinoids and terpenes, as well as contaminants such as pesticides, residual solvents, heavy metals, mycotoxins, pathogens, and foreign materials.

Radicle ACES is led by principal investigator Kelsey Laird, PhD, and co-investigator Jessica Saleska, PhD/MPH. Academic collaborators include Miroslav Backonja, MD (clinical professor, University of Washington), Chris Colwell, PhD (Professor, UCLA), Derek Loewy, PhD (director of behavioral sleep medicine at Scripps Clinic Sleep Center), Ethan Russo, MD (founder and CEO of CReDO Science), Kate Taylor, PhD (associate professor, UCLA), Jill Waalen, MD/MPH (co-director of biostatistics at Scripps Research), and more.

“The Radicle ACES study aims to answer lingering questions as to who should take cannabidiol, how much and for what conditions, as well as differing dosage patterns,” said Ethan Russo, MD, scientific expert for Radicle Science, and founder and CEO of CReDO Science, in a press release. “CBD is much more subtle in its effects and quite benign compared to THC. Patients are unclear on what product to choose and healthcare providers don’t yet have the data to counsel on proper dosage.”

Anonymized aggregate results will be released in October 2021.

Articles

The study will collect data on 13 CBD brands and a diverse population of 3000 participants.

Radicle Science launches study evaluating effectiveness of CBD products

Organifi (San Diego, CA), a maker of superfood blends that has an extensive customer base of over one million through its e-commerce platform, has announced it will be expanding into natural, specialty, and conventional brick-and-mortar retail channels. Through this omnichannel sales strategy, Organifi hopes to meet the growing evolution of grocery shopping habits. As of July, its products are now available in Sprouts worldwide, 600 CVS stores, King Sooper in the Denver region, and Fresh Thyme in the Midwest region, among other retailers.

“It’s always been about connecting with our community, meeting the needs of our customers, and delivering the absolute best-quality superfood blends that conveniently fit within a healthy lifestyle; beginning with our Organifi Green Juice and now offering nearly 20 products that meet different needs throughout the day,” said Mae Steigler, Organifi CEO, in a press release. “Growing our brand within the direct-to-consumer channel over the past several years has provided us the opportunity and access to listen to and learn from our customers, firsthand, allowing us to both grow and innovate strategically, before venturing into the retail landscape. I believe that will continue to be our most-valuable asset and a powerful contributor to our success on shelves.”

Since its inception, as a predominantly direct-to-consumer brand, Organifi has experience 55% year over year revenue growth. Until now, its only retail distribution was in Vitamin Shoppe, where it became the retailer’s #2-selling superfood brand in 2020.

“We’re in a highly-advantageous position, launching into some of the top retail accounts in the country for the first time,” said Adam Hertel, vice president of retail sales at Organifi. “With products already proven and validated by a wide range of consumers across markets and demographics, we have the exciting ability to leverage years of consumer insights, awareness and loyalty, accelerating Organifi to achieve the same category stewardship in-store, as we have online.”

Organifi expands into natural, specialty, and conventional retail channels after growing its brand in e-commerce

Direct-to-consumer brand Organifi announces omni-channel retail distribution strategy

Jennifer Grebow is the editor-in-chief of 

, an award-winning media-content provider in the dietary supplement and natural products market. 

, an MJH Life Sciences brand, provides insights and industry updates critical to manufacturers of dietary supplements, healthy foods, and nutritious beverages. 

 keeps industry abreast of current market trends, research updates, news, and regulatory developments. 

goes beyond the 24-hour news cycle and provides in-depth analysis to help industry players navigate the challenges and changes in the near- and long-term. 

, the largest privately held, independent, full-service medical media company in North America, dedicated to delivering trusted health care news across multiple channels.

Photo from Socati Corp. and Impact Naturals

Supplements brand Impact Naturals has worked with Socati Corp. (Austin, TX), a private labeler of hemp extract and CBD products, to produce a new line of CBD capsules the companies say provide better absorption, faster uptake, and longer-lasting effects.

The three new Impact Naturals products are Revive, Restore, and Rest. The products are based on a trademarked, broad-spectrum, high-absorption formula called Chylosoma, which contains the hemp cannabinoids cannabidiol (CBD) and cannabigerol (CBG) and cannabinol (CBN). The products are formulated with complementary ingredients such as ginseng, ginkgo, and melatonin. Revive is designed to energize, Restore is said to boost the endocannabinoid system, and Rest is designed to promote good sleep.

“Using our proprietary lipid-absorption technology, Impact Naturals’ products allow cannabinoids to take advantage of the body’s existing lipid transport system, boosting absorption and delivery throughout the body,” said James Lowder, MD, chief medical officer at Impact Naturals, in a press release. The firms say that independent study data demonstrated the products deliver improved CBD absorption and a quicker onset.

The products are based on a trademarked, broad-spectrum, high-absorption formula called Chylosoma, which contains the hemp cannabinoids cannabidiol (CBD) and cannabigerol (CBG) and cannabinol (CBN). 

Private-label hemp supplier Socati helps Impact Naturals launch high-absorption CBD line

Brian Wommack. Photo from Council for Responsible Nutrition.

The Council for Responsible Nutrition (CRN; Washington, DC) has appointed its Senior Vice President of Communications Brian Wommack as the new executive director of the CRN Foundation. The CRN Foundation is a member-driven, nonprofit 501(c)(3) foundation providing consumers, researchers, and healthcare practitioners with information about dietary supplements and their role in a healthy lifestyle.

As part of the latest strategic plan put forth by the CRN Board of Directors, the foundation will focus on helping prioritize access to dietary supplements and functional food, as well as nutrition education. The Board of Directors recently created an Access Task Force, led by Micah Osborne, president of industry ingredient supplier Stratum Nutrition (Carthage, MO). “Its objectives are to define and explore opportunities surrounding accessibility, leverage the CRN Foundation for ways to achieve access goals through its 510(c)(3) charitable status, and enhance member experience and engagement through doing good works,” stated a foundation press release. It aims to launch a new, multi-year initiative to promote information connecting the benefits of supplements and functional food with better nutrition and health, and to improve consumer access to supplements.

“CRN’s Board recognizes that the industry can play a critical role in addressing disparities in healthcare and nutrition, and Brian has the talents and vision to lead this initiative,” said CRN’s president and CEO, Steve Mister, in the press release.

“A large percentage of the population doesn’t have access to nutrient-dense food. Accepting a role to help solve these problems was a no-brainer,” said Wommack.

The CRN Foundation is a member-driven, nonprofit 501(c)(3) foundation providing consumers, researchers, and healthcare practitioners with information about dietary supplements and their role in a healthy lifestyle.

CRN names Brian Wommack executive director of CRN Foundation

Alissa Marrapodi is Industry Insights Contributor, Custom Content Editor, MJH Life Sciences.

Twelve semi-finalists in the third edition of the Real California Milk Excelerator were announced by The California Milk Advisory Board (CMAB; Tracy, CA) and innovation consultancy VentureFuel. The finalists will compete for over $650,000 in prize funds to support the development of dairy products that promote personal performance (focus, energy, etc.) and recovery benefits (rejuvenation, relaxation, etc.).  

“This competition is designed to inspire new ideas integrating the natural benefits of real milk and dairy products as functional ingredients, delivering a flavor and nutritional profile that’s hard to beat. This year’s entries demonstrate the versatility of these ingredients and how they can be used in endless formulations,” said John Talbot, CEO of the CMAB, in a press release. “Just as our definition of health has evolved, our desire for functional benefits from our food and beverage choices has evolved with it. Our 12 finalists certainly capture this evolution, with every manner of benefit, from maximum athletic performance to gut-health and even sleep support—all in relevant formats that will appeal to today’s consumers.”

Fred Schonenberg, founder of VentureFuel Inc., who is partnering with CMAB for a third consecutive year to direct the program, said in a press release: “Each year we see such disruptive and unique products, built specifically around consumers’ evolving needs and wants. This year’s applicants were particularly inspiring as each sought to create better-for-you products that can improve and sustain the many ways we define health. We saw applications from Australia to Austin, from local dairy farmers to PhDs to celebrity chefs, all tapping into the natural nutritional value of real dairy. Now we move to accelerating these businesses to drive commercial growth through mentorship, strategic resources and introductions to buyers and investors.”

Each semi-finalist’s product’s first ingredient is cow’s milk dairy, making up at least 50% of the formula. Should they win the competition, the startups have committed to producing the product in California, with milk from California dairy farms. Each semi-finalist accepted into the cohort will receive $10,000 to develop their product further while receiving a suite of resources including lab or kitchen time, graphic design, consumer insights, and elite mentorship from global marketing, packaging, and distribution experts. The first-place winner will receive up to $150,000 worth of additional support and the second-place winner, $100,000 worth of additional support to accelerate the commercialization of their product to market.

Semi-finalists will participate in a series of mentoring and support events leading up to the virtual pitch event semi-finals in November, where four companies will be selected for a final virtual event to select the Excelerator winner. 

In addition to the semi-finalists, two companies have been selected to participate in the new Real California Milk Incubator Boot Camp program, which was built to assist ideas and promising prototypes that are too early for the Excelerator. These two companies — Darvida and Perfect by Nature — will receive mentoring and support from VentureFuel, CMAB, and the California Dairy Innovation Center (CDIC).

The finalists will compete for over $650,000 in prize funds to support the development of dairy products that promote personal performance (focus, energy, etc.) and recovery benefits (rejuvenation, relaxation, etc.).

12 semi-finalists announced for Real California Milk Excelerator

Danone North America’s partnership with Brightseed

 (San Francisco, CA), creator of Forager artificial intelligence, Danone SA (Paris-Saclay, France) announced that it will be expanding the partnership into a three-year strategic collaboration to build unparalleled understanding of the world’s most common crops, and explore lesser known plant sources. Out of this partnership, Danone hopes to establish the blueprint for a health-forward and regenerative food system while accelerating the firm’s development of category-leading plant-based foods. As an example of what’s already been accomplished during Danone North America’s partnership with Brightseed, the Forager AI uncovered 10 times more bioactives than previously known and seven new health areas, in a single plant, in a matter of months.

“At Danone, we support health by making it as accessible as possible through food. By partnering with Brightseed, we now have tools to shift the global food-system from one that is yield-driven to one that prioritizes sustainability and health beyond all else,” said Taisa Hansen, senior vice president of research and innovation at Danone Nutricia Research, in a press release. “Forager is providing unprecedented visibility into the transformative power plants can have on human health. Ultimately our goal is to make this information non-exclusive so that humanity can benefit from this collective wisdom and move faster towards a healthier, regenerative food future.”

Currently, less than 1% of bioactives in plants are known to science, and only 12 plants, such as corn, rice, wheat, soy, and oats account for 75% of the global food system. Brightseed’s AI can help identify new biological connections between the bioactives present in these plant sources and human health so their untapped potential can be mined and new territories for plant-based innovation can be explored.

“Brightseed and Danone share the belief that the health of people and the health of the planet are interconnected,” said Sofia Elizondo, co-founder and COO of Brightseed. “Through unprecedented access and open data exchange between Danone and Brightseed, we are breaking down the silos that have traditionally kept the food and health industries worlds apart.”

“Leading food companies are increasingly interested in providing products that help to nourish and sustain wellness in their customers, rather than products that contribute to disease,” added Dariush Mozaffarian, MD, DrPH, professor at the Friedman School of Nutrition Science & Policy at Tufts University in Boston and Brightseed scientific advisor. “Artificial intelligence is a promising way to improve our molecular understanding of plants and foods, so that we can find newer ways to address chronic diseases, improve nutrition security, and promote healthy living.”

According to Brightseed, the firm’s AI will map all of the approximately 10 million bioactive compounds in the plant kingdom to their health impacts by 2025.

Danone expanded its partnership with Brightseed to accelerate knowledge of plant bioactives and their health benefits.

Danone expands partnership with Brightseed to accelerate knowledge of health benefits in plants

Ito En and Taiyo International have partnered to supply matcha for food, beverage, and supplement industries in North America. As part of the partnership Taiyo is introducing Ito En’s ceremonial matcha to its existing portfolio of culinary organic matcha powder and ceremonial matcha powder.

“Taiyo is proud to partner with Ito En, which rounds out our overall green tea portfolio. It is exciting to blend our B2B strengths with Ito En’s consumer-facing expertise,” said Scott Smith, vice president of Taiyo International, in a press release.

“We are very pleased to partner with Taiyo International, having expertise in the North American food and supplement markets. It will enable us to explore new product offerings to American consumers in addition to our product lineup of beverage, tea bags, and tea powder,” said Naritoshi Tomisawa, head of international business of Ito En Ltd. Japan.

Familiarity with matcha has grown quite a bit thanks in part to high end coffee shops and specialty brands who have introduced the product to a broader audience. As its popularity grows, consumers are becoming more sophisticated about matcha, says Smith. “The timing of this partnership between Taiyo and Ito En is ideal due to the growing demand for the flavor of authentic organic matcha as well as its health benefits,” he states.

Taiyo International and Ito En partner to meet North American demand for quality matcha.

Leaders in green tea, Ito En and Taiyo, partner to meet North American demand for matcha

InVivo Biosystems (Eugene, OR), a specialist in genetic small-animal model creation and 

testing, has launched a new platform to analyze how compounds such as nutrients can affect lifespan and healthspan. The platform’s 

modeling data can be correlated to humans. Its purpose is to help healthy-aging companies research and develop ingredients and products faster and to substantiate claims and IP patents with scientific evidence.

The new InVivo Longevity Platform uses a non-vertebrate model that provides lifespan and healthspan measurements by monitoring survival, morphology, and movement in simple animal models. The platform can also help identify pathways that contribute to any observed extension of lifespan or healthspan using whole transcriptome sequencing.

The firm says it can often be difficult to gather data on life-extending compounds that can be directly correlated to human data. “This new platform gives InVivo Biosystems’ customers access to actual lifespan impacts and correlates that with deep molecular information in known aging pathways,” the company explains. The system can provide information on how a compound affected mitochondrial and oxidative stress or transcriptional changes related to aging. “The new InVivo Longevity Platform informs product development teams on the impact of the compound formulation on lifespan, the activity level and muscle use throughout senescence, and the underlying mechanism of action (MoA),” the company further explained in a press release.

This data will be key for companies looking to develop IP and file patents based on substantiated claims, and gives companies an advantage in the increasingly competitive longevity market.

“Health-conscious consumers are looking for products that deliver the advertised benefits of what they say they can do,” the press release states. “Using the proprietary InVivo Longevity Platform helps firm assess product performance by generating concrete efficacy data. The platform ensures accuracy, reproducibility, and robust conclusions by combining continuous automated data collection of lifespan metrics and genetic analysis.”

The platform also helps companies develop products more quickly using the data provided. “The new platform helps companies prioritize development pipelines by giving them actionable, quantitative information about how candidate formulations combat aging and age-related conditions,” said Matt Beaudet, CEO, InVivo Biosystems, in the press release. “Using the best non-vertebrate model for longevity and healthspan studies, InVivo Longevity Platform specializes in giving clients a full picture of how each compound or test article impacts several key pieces of the aging puzzle.” The company says that, on average, work on an InVivo Longevity Platform project can be completed in less than five months, from ideation to final report.

InVivo says these types of testing capabilities have traditionally been available mostly to university laboratories, and that the InVivo Longevity Platform now makes those tools accessible to industries. Of note, the company says it can also assist clients with preparing and filing patent applications. It says it’s already worked with hundreds of clients in recent months to test the new platform.

InVivo says that the age-tech and longevity industry is expected to grow three-fold by 2050.

Its purpose is to help healthy-aging companies research and develop ingredients and products faster and to substantiate claims and IP patents with scientific evidence.

New platform lets nutraceutical firms analyze how healthy-aging ingredients and formulas might extend lifespan, healthspan

Jennifer and Sebastian interview Ashish Talati, a partner at Amin Talati Wasserman. Talati will discuss how the CBD market in the U.S. could change if CBD is one day legalized for use in dietary supplements.

Ashish Talati, a partner at Amin Talati Wasserman

Podcasts

If Congress legalizes use of CBD in dietary supplements and food tomorrow, what's next?

The Nutritional Outlook Podcast Episode 2: What happens if CBD becomes legal?

 introduces The Nutritional Outlook Podcast. The new podcast will take listeners beyond the pages of the magazine. It digs deeper into key discussions and ideas happening among stakeholders in the dietary supplement, functional food, and natural products industries. In this episode, you will be introduced to Jennifer Grebow, editor-in-chief, and Sebastian Krawiec, editor, as they discuss their backgrounds and break down the premise of the podcast and its goals.

Nutritional Outlook introduces The Nutritional Outlook Podcast.

Featured Content

Pain Claims: Navigating pain-relief supplement claims